MAUDE Adverse Event Report: ENCORE MEDICAL L.P. REAMER; RSP GLENOID HALF-MOON REAMER, STARTER

Catalog Number	804-06-012
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure: surgeon complaining of ineffective glenoid reaming with these instruments.Chronic issue as the instruments were blunt.The blunted blade does not ream bone.Poor design and blunt blades.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
1644408-2022-00256 was reassessed and determined to be non-reportable.

• Brand Name: REAMER
• Common Device Name: RSP GLENOID HALF-MOON REAMER, STARTER
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 13590888
• Report Number: 1644408-2022-00256
• Device Sequence Number: 12005378
• Product Code: HTO
• UDI-Device Identifier: 00888912148757
• UDI-Public: (01)00888912148757
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 804-06-012
• Device Lot Number: 236237L01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 804-06-013 LOT 254478L01.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female